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Cervical Device Contraception-2 (Nanopaz) (NANOPAZ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Bnai Zion Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT00689494
First received: May 19, 2008
Last updated: June 2, 2008
Last verified: June 2008
History of Changes
  Purpose

Measure blood progesterone by using cervical device contraception.


Condition Intervention Phase
Healthy
 Other: Nanopaz contraception device
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cervical Device Contraception

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • blood progesterone measure in blood [ Time Frame: one to two months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: June 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Nanopaz contraception device
    levonorgestrel and levonorgestrel device for cervical contraception-nantechnolgy method
    Other Name: levonorgestrel device for cervical contraception-nantechnolgy method
Detailed Description:

A very small cervical device that releases small amount of progesterone 20 mcgm/day.

The target of the research is to measure blood progesterone by using the cervical device.

This small device delivers progesterone by nanotechnology method.

  Eligibility

Ages Eligible for Study:   1 Month to 2 Months
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 10 healthy women are candidate for hysterectomy

Exclusion Criteria:

  • Women with neoplastic malignancy disease or thrombophylia
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Baram Paz, Bnai Zion MC
ClinicalTrials.gov Identifier: NCT00689494     History of Changes
Other Study ID Numbers: BnaiZionMC-08-BP-003-CTIL
Study First Received: May 19, 2008
Last Updated: June 2, 2008
Health Authority: Macedonia: Ethics Committee

Keywords provided by Bnai Zion Medical Center:
Nanopaz device
Blood progesterone measure in using the device
Delivery progesterone
Progesterone levonorgestrel

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 19, 2013